The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT04033679|
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia;Schizoaffective||Other: Active TDCS Other: Sham TDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participant randomly assigned to receive either TDCS stimulation or sham stimulation.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double blind|
|Official Title:||The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia|
|Estimated Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||April 30, 2023|
Experimental: Active TDCS
In the active condition, a constant current of 2 mA intensity will be applied for 20 min to the parietal regions, using P3 as the cathode and P4 as the anode.
Other: Active TDCS
Participants will receive active TDCS stimulation.
Sham Comparator: Sham TDCS
In the sham condition, stimulation will be administered using the same parameters at the site of active treatment, but the current will be turned off after 30 seconds.
Other: Sham TDCS
Participants will receive sham TDCS stimulation.
- Medication adherence - Pill Count [ Time Frame: During 3-month follow up phase ]Pill count or percentage of weekly antipsychotic medication adherence will be assessed during the 3-month follow up phase after TDCS is completed.
- Medication adherence - Plasma Monitoring [ Time Frame: Blood concentration of antipsychotic medication will be measured on day of the first TDCS session before TDCS starts, after 1 week of TDCS is completed, after 2 weeks of TDCS are completed, and during the 3-month follow up phase. ]Blood concentrations of antipsychotic medication will be measured at different points in the study to assess medication adherence.
- Medication adherence - Clinician Rating [ Time Frame: During 3-month follow up phase ]The Clinician Adherence Rating Scale is a 7-point clinician rated measure which takes into account patients' self-report, medication adherence, and changes in plasma concentrations to provide a comprehensive assessment of antipsychotic medication adherence. A higher score represents greater adherence.
- Insight into Psychosis [ Time Frame: Illness awareness will be assessed before the TDCS phase begins, after 2 weeks of TDCS are completed, and during the 3-month follow up period ]Level of illness awareness will be assessed by the VAGUS Insight into Psychosis scale. The VAGUS assesses the core domains of insight into psychosis. VAGUS has both self-report and clinician-rated versions with good inter-scale reliability and test-retest reliability. Higher scores indicate better insight into illness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033679
|Contact: Philip Gerretsen, MD, PhD||416-535-8501 ext firstname.lastname@example.org|
|Contact: Ariel Graff, MD, PhD||416-535-8501 ext email@example.com|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5T 1R8|
|Contact: Philip Gerretsen, MD, PHD 416-535-8501 ext 39426 firstname.lastname@example.org|
|Contact: Ariel Graff, MD, PHD 416-535-8501 ext 34834 email@example.com|
|Principal Investigator:||Philip Gerretsen, MD, PhD||Centre for Addiction and Mental Health|